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510(k) K964843

IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT by Beckman Instruments, Inc. — Product Code JZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1997
Date Received
December 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Factor B, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5320
Review Panel
IM
Submission Type

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Other clearances for product code JZH

  • K882623 — PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM (July 8, 1988)
  • K831959 — RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (July 19, 1983)
  • K811740 — KALLESTAD'S ENDOPLATE FACTOR B TEST (July 16, 1981)
  • K781016 — C3PA (GBG) PROPERDIN FACTOR B (August 14, 1978)
  • K772084 — LAS-R HUMAN C3 PROACTIVATOR TEST (January 24, 1978)